ROPINIROLE HYDROCHLORIDE (Page 9 of 9)

Package/Label Display Panel

ROPINIRole Tablets, USP

0.25 mg*

10 Tablets

Bag
(click image for full-size original)

Package/Label Display Panel

R OPINIRole Tablets, USP

1 mg*

10 Tablets

Bag
(click image for full-size original)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7888(NDC:0904-6373)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Circular, Biconvex) Size 7mm
Flavor Imprint Code H;121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7888-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-7888-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090429 10/01/2014
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7633(NDC:0904-6374)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C BLUE NO. 2
ALUMINUM OXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN Score no score
Shape ROUND (Circular, Biconvex) Size 7mm
Flavor Imprint Code H;123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7633-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-7633-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090429 10/01/2014
Labeler — Cardinal Health 107, LLC (118546603)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 118348161 REPACK (55154-7888), REPACK (55154-7633)

Revised: 12/2022 Cardinal Health 107, LLC

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